Health-related Quality of Life and Functional Impairments After Intensive Care Unit Discharge (CritiQoL2)

Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study

Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are marked by an increase in morbidity.

Indeed, independently of the initial disease, it is currently recognized that an admission to the ICU can be experienced as a traumatic situation, with potential physical, psychological and cognitive impairments that can be described by the term "post-intensive care syndrome" (PICS). This results in a decrease in quality of life compared to the general population.

Health-related quality of life (HRQoL)has received increasing attention in the literature. Thus, many studies have been interested in its evaluation, in particular in certain pathologies such as acute respiratory distress syndrome (ARDS), sepsis, cardiac arrest or in patients with onco-hematological diseases.

Paradoxically, few studies have described the HRQoL and the elements of the PICS in the overall population of patients admitted to the ICU. However, a better understanding of these elements could allow us to propose improvement strategies to facilitate the rehabilitation of these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Health-related Quality of Life

Detailed Description

The investigators therefore propose the constitution of a longitudinal cohort evaluating the HRQoL, and allowing the analysis of its determinants in the global population of intensive care patients.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Gwenaëlle JACQ, RN, MSc; Phone Number: 0139638356; Email: gjacq@ch-versailles.fr

Study Locations

• France
  • Le Chesnay, France
    • Versailles Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients who meet the eligibility criteria will be offered participation in the study.

Description

Inclusion Criteria:

• all adult patients(age>18) hospitalized in ICU

Exclusion Criteria:

• legal guardianship
• opposition to participate
• unread and unwritten French language

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of an overall HRQOL and ii) percentage functional impairments in the global population of intensive care unit survivors,2 years after ICU discharge.according to the score to following scales :	i)36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status. ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap. Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency. The Fatigue Severity Scale(fatigue)-Ranging score[9-63],a high score indicate a greater fatigue severity. The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considered normal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.	24month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or not of elements associated with i) HRQOL impairements defined by ii)physical and/or psychological and /or cognitive impairments in the global population and in differents sub-groups of interest, according to the to following scales :	i)36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status. ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap. Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency. The Fatigue Severity Scale(fatigue)-Ranging score[9-63],a high score indicate a greater fatigue severity. The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety The Impact of Event Scale-Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considered normal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal..	24 month

Collaborators and Investigators

• Sponsor: Versailles Hospital
• Collaborators: Legriel Stéphane
• Investigators: Principal Investigator: Gwenaëlle JACQ, RN,MSc, Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Morbidity; Health-related quality of life; Post intensive care syndrome; Long terms outcomes
• Other Study ID Numbers: P21/07_CritiQol2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No